Kornimate/medical-research-clean huggingface dataset:
a study of kk2269 in adult participants with solid tumors

Conditions: Advanced Solid Tumor; Metastatic Solid Tumor; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma; Non Small Cell Lung Cancer

Summary: this is a first-in-human study of kk2269. part 1 and part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in part 1. in part 1, the primary objective is to assess the safety and tolerability of kk2269. in part 2, only participants with gastric adenocarcinoma, gej adenocarcinoma, esophageal adenocarcinoma, or nsclc who have experienced at least one systemic therapy will be enrolled. in part 2, the primary objective is to assess the safety and tolerability of kk2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of kk2269 in combination with docetaxel for subsequent studies. in both part 1 and part 2, participants who refuse to undergo standard therapy are also eligible.


Eligibility criteria:
* key common inclusion criteria for parts 1 and 2: * patients who are ≥ 18 years old at the time of informed consent * patients who have disease measurable by recist v1.1 * patients with an ecog ps of 0 or 1 * patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator * the specified periods have passed respectively after the completion of previous cancer treatments as of the date of enrollment * patients who agree to use a medically effective method of contraception * key additional inclusion criterion for part 1: •patients with histological or cytological evidence of at least one locally advanced or metastatic non-cns solid tumor * key additional inclusion criteria for part 2: * patients with histological or cytological evidence of any of the following disease: * gastric adenocarcinoma, gej adenocarcinoma, or esophageal adenocarcinoma * nsclc * patients who are suitable for docetaxel treatment * key common exclusion criteria for parts 1 and 2: * patients with an uncontrolled or serious intercurrent illness * patients with known active central nervous system metastasis * patients with a history of ≥ grade 3 allergic reaction to any antibody drug * patients with a history of autoimmune disease * patients with a history of hiv, hbv, or hcv at screening * patients who have a history of primary immunodeficiency * key additional exclusion criterion for part 2: * patients with a history of treatment with docetaxel
longitudinal, multi-dimensional assessment of recovery and added benefit of a behavioral health intervention for children with abusive head trauma

Conditions: Non-Accidental Traumatic Head Injury to Child

Summary: family dynamics and caregiver responses to a child with traumatic brain injury are implicated both as precipitating events as well as factors influencing outcomes of abusive head trauma (aht). however, no family behavioral health intervention exists to meet the unique needs of families with infants and very young children with aht. the study was initially designed as a randomized controlled trial (rct) to assess the efficacy of an evidence-based behavioral intervention to improve outcomes for families and children with aht. however, rates of recruitment were so low that the investigators and funder amended the study to be intervention only (with irb approval). at that time, there were five participants and only one had been assigned to the intervention arm. only one additional family was recruited, and that family did not complete study measures prior to the time at which the intervention would start and did not receive the intervention. the investigators did examine outcomes in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and service usage over time but connot compare to patients not receiving the intervention. the investigators were not able to examine characteristics of patients and families best suited for this behavioral health intervention.

27 children (ages 3 months to 2 years) and their caregiver referred to the non-accidental brain injury care clinic at the children's hospital colorado (chco) were recruited for participation in the study, 7 families consented. one family received the attachment and biobehavioral (abc) intervention. one family discontinued participation. the data collection schedule was 1 month post-injury, 3 months, 6 months, 9 months, and 12 months. outcomes in multiple dimensions, were assessed including clinical recovery, cognitive, language, and motor functioning, family functioning, caregiver mental health including anxiety, depression, competency, and stress. the investigators also examined service use over time. analyses will assess trajectories of recovery for both groups using data for all time points.

Eligibility criteria:
inclusion criteria: * children who have experienced aht as determined by the chco child protection team * caregivers who speak english * families who live in the denver metro area and, * child-victim age between 3 months and 2 years of age exclusion criteria: * those with significant disability that would inhibit participation in the intervention, * those scoring below 6 months on developmental measures will not be eligible.
water load test value for hyponatremia

Conditions: SIAD - Syndrome of Inappropriate Antidiuresis; Hyponatremia

Summary: acute water load test has been using to diagnose renal ability to excrete water for decades. latest recommendations for the diagnosis of hyponatremia do not recommend performing such a test. the investigators aim at, retrospectively, study the value of acute water load test in patients suffering from a syndrome of inappropriate antidiuresis.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old at the time of the test * affiliated to a social insurance system * water load test performed at the renal and metabolic diseases unit of the european george pompidou hospital, ap-hp, paris, france * between 01/01/2001 and 12/31/2019 exclusion criteria: * hypernatremia and/or polyuria-polydipsia (diabetes insipidus) * hyponatremia due to a tea and toast syndrome and/or a beer potomania * hyponatremia due to a high (or normal) osmolality related to diabetes mellitus, hyperproteinemia and/or intoxication * chronic kidney disease with an estimated glomerular filtration rate (egfr) by the mdrd formula \<60 ml/min/1.73m2 * hyponatremia related to thiazides * hyponatremia related to an hypovolemic status * syndrome of inappropriate antidiuresis related to an endocrine disorder (such as hypothyroidism or adrenal insufficiency)

Keywords: hyponatremia siad water load test
observational study in cll patients receiving br

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this observational study is to provide additional data to confirm the safety profile and efficacy of bendamustine and rituximab (br) chemotherapy for chronic lymphocytic leukemia patients with significant comorbidities treated in routine clinical practice.

br (bendamustine, rituximab) combination is currently accepted as a first-line treatment of chronic lymphocytic leukemia (cll) in patients for whom fludarabine combination chemotherapy is not appropriate. the objective of this observational study is to provide additional data to confirm the safety profile and efficacy of br for cll patients treated in routine clinical practice. specific data of interest are: comorbid conditions, cll characteristics, adverse events, reasons for discontinuation br, overall response rates, complete response rate, progression-free survival, overall survival.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of chronic lymphocytic leukemia * patients treated with first-line br for active disease requiring treatment * cumulative illness rating scale (cirs) \> 6 * informed consent to data collection exclusion criteria: * patients treated with br within prospective clinical trials

Keywords: chronic lymphocytic leukemia bendamustine rituximab
s8516-s8736-s9125-s9240 research study of genes in tissue samples from patients with b-cell non-hodgkin lymphoma

Conditions: Lymphoma

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is looking at genes in tissue samples from patients with b-cell non-hodgkin lymphoma.

objectives: * to determine if toxicity following treatment for lymphoma varies according to genetic polymorphisms in oxidative stress-related genes (i.e., sod2, cat, gpx1, gstm1, and gstp1). * to assess whether these genetic polymorphisms are associated with progression-free survival and/or overall survival in these patients treated for lymphoma. outline: previously collected samples are used for biomarker analysis.

Eligibility criteria:
disease characteristics: * diagnosis of aggressive b-cell non-hodgkin lymphoma * previously treated with curative intent using anthracycline-based therapies * previously collected paraffin-embedded diagnostic tissues from clinical trials that were collected as part of swog treatment protocols (s8516, s8736, s9125, s9240, and s9349) available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: non-hodgkin lymphoma cutaneous b-cell non-hodgkin lymphoma extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone b-cell lymphoma
ultrasound prediction for vocal cord dysfunction in patients scheduled for anterior cervical spine surgeries

Conditions: Vocal Cord Dysfunction

Summary: • anterior cervical discectomy and fusion (acdf) is a highly effective and safe method for spinal cord and cervical root decompression. vocal cord paralysis secondary to recurrent laryngeal nerve injury is a common complication after acdf. the incidence reported as high as 22%. the standard technique for vocal cord evaluation and the most commonly used tool is direct laryngoscopy. laryngoscopy causes patients annoyance and could potentially contribute to poor patient compliance. ultrasonography is a non-invasive technique that is used as an alternative tool.

1. design: a prospective cohort study. 2. sample size: assuming that the target population is 240 and positive predictive value of transcutaneous laryngeal ultrasonography is 89.4%. so, the sample size is 91 cases using open source epidemiologic statistics for public health (openepi) with confidence interval 95% and power of test is 80%. all patients underwent transcutaneous laryngeal ultrasonography examination by both anterior and lateral approach of the vocal cords (vcs) before the surgery, immediately after extubation, 2 h, 12h, 24 and 48hour postoperatively by an anesthesiologist with an experience of at least three years in ultrasonography scan.

Eligibility criteria:
inclusion criteria: * patient acceptance. * both sex * age (21-60) years old. * american society of anesthesiologist i / ii * elective anterior cervical spine surgeries * patient with body mass index (25-35 kg/m²) exclusion criteria: * patient refusal. * altered mental status. * patients with per-existing neurological or thyroid disease affecting vocal cord function. * patients with a diagnosis of primary untreated laryngeal/hypopharyngeal cancer. * patient with a history of thyroidectomy affecting recurrent laryngeal nerve. * patient with a history of laryngeal trauma. * pre-operative voice abnormalities.
a study to evaluate the safety and immunogenicity of gsk biologicals' seasonal influenza vaccine in adults

Conditions: Influenza

Summary: this study is designed to test the immunogenicity and reactogenicity of the fluarix™/influsplit ssw® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female aged 18 years or above at the time of the vaccination. * written informed consent obtained from the subject. * healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study. * if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. * administration of an influenza vaccine within 6 months preceding the study start. * administration of an influenza vaccine other than the study vaccine during the entire study * clinically or virologically confirmed influenza infection within 6 months preceding the study start * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * not stabilized or clinically serious chronic underlying disease. * lactating female. * history of chronic alcohol consumption and/or drug abuse. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Keywords: influenza
phase ii/iii study of the tolerance and efficacy of combined use of didanosine (2',3'-dideoxyinosine; ddi) and lentinan in hiv-positive patients

Conditions: HIV Infections

Summary: to determine the tolerance and side effects of a combination of lentinan and didanosine (ddi) in comparison with ddi alone. to determine whether the combination of lentinan and ddi produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase in one or more of the following: neutrophil count and activity, t-cell subsets, and a decrease in p24 antigen.

patients are treated with daily oral ddi for 6 weeks, then are randomized to ddi in combination with intravenous lentinan or placebo (administered once weekly) for 26 weeks. patients who are already stabilized on 400 mg/day ddi will proceed directly to randomization. following completion of the combination therapy, patients may be offered 26 additional weeks of therapy on an optional basis.

Eligibility criteria:
inclusion criteria patients must have: * hiv seropositivity. * absolute cd4 count of 200 - 500 cells/mm3. * no active opportunistic infection or kaposi's sarcoma. prior medication: allowed: * prior ddi for no longer than 3 months. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * lymphoid malignancy. * pancreatitis. * peripheral neuropathy. * critical illness. concurrent medication: excluded: * antiretroviral agents other than ddi. * steroids. * cytotoxic agents. * immunosuppressive agents. * immunomodulators. * 1-thyroxine. concurrent treatment: excluded: * radiotherapy. prior medication: excluded within 1 month prior to study entry: * antiretroviral agents other than ddi (patients may have received prior ddi for no longer than 3 months total). * steroids. * cytotoxic agents. * immunosuppressive agents. * immunomodulators. prior treatment: excluded: * radiotherapy within 1 month prior to study entry. active iv drug abuse.

Keywords: didanosine drug therapy, combination acquired immunodeficiency syndrome aids-related complex lentinan
bismuth-metronidazole triple therapy for h. pylori first-line treatment

Conditions: Helicobacter Pylori Infection

Summary: this randomized controlled clinical trial will compare the eradication efficacy of bismuth-metronidazole triple therapy (ppi+bismuth+ metronidazole) with that of bismuth-metronidazole quadruple therapy (ppi+bismuth+ metronidazole+ amoxicillin) for helicobacter pylori first-line treatment. the completion of this trial will expand new therapy for the treatment of helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility criteria:
inclusion criteria: * participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (icf). * 18-75 years old on the day of signing the icf. * helicobacter pylori infection confirmed by 13c-urea breath test or rapid urease test. * have not received helicobacter pylori eradication treatment before. exclusion criteria: * have received hp eradication treatment. * patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. * subjects or guardians refused to participate in the trial. * alcohol and/or drugs abuse (addiction or dependence) or poor compliance with doctor's judgment. * have taken antibiotics, bismuth, ppi or chinese traditional medicine 4 weeks before treatment. * pregnant or lactating women. * active peptic ulcer. * allergic to drugs used in the trial. * any other circumstances that are not suitable for recruitment.
optimization and evaluation of the diagnosis and treatment system for diabetic retinopathy in type 2 diabetes mellitus

Conditions: Diabetes; Diabetic Retinopathy; Type 2 Diabetes Mellitus (T2DM)

Summary: this study aims to integrate clinical indicators and features of fundus images, combined with metabolomics, to construct an early warning model for diabetic retinopathy (dr) in type 2 diabetes. by combining clinical indicators with metabolomics, the investigators aim to establish a precise dr typing model based on the age of diabetes onset (early-onset diabetes, late-onset diabetes) and based on the coexistence with two types of diabetic macrovascular complications. a multidisciplinary collaboration will be conducted for comprehensive management of dr to control the progression of moderate-stage dr. cloud-based patient rooms combined with continuous glucose monitoring (cgm) will further explore the role of integrated diabetes retinopathy ward management models in the management of patients undergoing diabetes retinopathy surgery, pioneering a new model for the management of advanced dr.


Eligibility criteria:
inclusion criteria: * meets the diagnostic criteria for type 2 diabetes in the "china type 2 diabetes prevention and treatment guidelines (2020 edition)"; * aged between 20 and 79 years old, without other severe underlying diseases; ③ possesses full cognitive and literacy abilities; ④ volunteers to participate in this study and are willing to sign an informed consent form. exclusion criteria: * those who have been diagnosed with type 1 or other types of diabetes; * those with severe cardiac, pulmonary, hepatic, or renal insufficiency; * those with mental confusion, speech disorders, or dementia, etc.; * those who are unable to take care of themselves, bedridden, or have mobility impairments; ⑤ women who are breastfeeding or pregnant; * those with a recent history of surgery, trauma, acute major vascular complications, or infectious diseases.
camera qualification study

Conditions: Diabetic Retinopathy

Summary: a multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with idx-dr.

a multi-center study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with idx-dr.

Eligibility criteria:
inclusion criteria: 1. 22 years of age or older 2. documented diagnosis of diabetes mellitus, as per any of the following: 1. having met the criteria established by either the world health organization (who) or the american diabetes association (ada) 2. hemoglobin a1c (hba1c) ≥ 6.5% 3. fasting plasma glucose (fpg) ≥ 126 mg/dl (7.0 mmol/l) 4. oral glucose tolerance test (ogtt) with two-hour plasma glucose (2-hr pg) ≥ 200 mg/dl (11.1 mmol/l), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water 5. symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (rpg) ≥ 200 mg/dl (11.1 mmol/l) 3. ability to understand and the willingness to sign a written informed consent document exclusion criteria: 1. currently participating in an interventional eye study 2. has a known allergy to or contraindication for the use of tropicamide 1% or other mydriatic eye drops 3. has a condition that, in the opinion of a licensed clinical team member or investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation) 4. pregnancy 5. self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters 6. history of laser treatment of the retina, injections into either eye, or any history of retinal surgery 7. previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion) 8. any condition that is contraindicated for the use of the study camera 9. contraindication for imaging by devices used in the study due to any of the following: 1. subject is hypersensitive to light 2. subject recently underwent photodynamic therapy (pdt) 3. subject is taking medication that causes photosensitivity
pharmacokinetic study of 48-hour sevoflurane inhalation using a disposable delivery system (anaconda©) in icu patients with acute kidney injury

Conditions: Acute Kidney Injury

Summary: describing a pharmacokinetic model of 48-h sevoflurane sedation in icu patients with acute kidney failure

prospective clinical monocentric study in icu with sedated ventilated patients (presenting acute kidney failure) with sevoflurane during 48 h with the anaconda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Eligibility criteria:
inclusion criteria: - adult patients ventilated more than 48 h stable respiratory and hemodynamic conditions consent of patients or family arterial line akin score = 3 exclusion criteria: * bmi \<30 sevoflurane anaphylaxia

Keywords: pharmacokinetics sevoflurane acute kidney injury sedation icu patients